Slide 1: Multimodal Spectroscopy as a Triage Test for Women at Risk for Cervical Neoplasia
MULTIMODAL SPECTROSCOPY AS A TRIAGE TEST FOR WOMEN AT RISK FOR CERVICAL NEOPLASIA: RESULTS OF A 1 1,607 607 SUBJECT PIVOTAL TRIAL Leo B. Twiggs, M.D. Chair, Department of Obstetrics and Gynecology University of Miami Miller School of Medicine Chief of Service Service, Jackson Memorial Hospital LuViv
Slide 2: Disclosure
Leo BB. Twiggs Twiggs, M M.D. D Chair, Department of Obstetrics and Gynecology University of Miami Miller School of Medicine Chief of Service, Jackson Memorial Hospital Disclosure Advisory Boards Merck GSK Lily G id d Th Guided Therapeutics ti St Study d supportt LuViva Advanced Cervical Scan
Slide 3: Pivotal Trial Clinical Sites
Pivotal Trial Clinical Sites University of Texas Southwest – Dallas, Texas Principal Investigator – Claudia Werner, MD Emory University School of Medicine – Atlanta, Georgia Principal Investigator – Lisa C. C Flowers, Flowers MD University of Miami – Miami, Florida Principal Investigator – Leo B. Tw
Slide 4: Results of a 1,607 Subject Pivotal Trial
Multimodal Spectroscopy as a Triage Test For Women at Risk For Cervical Neoplasia: Results of a 1,607 Subject Pivotal Trial Funding in part by The National Cancer Institute The Georgia Research Alliance Leo Twiggs, Nahida Chakhtoura University of Miami Women’s Women s Hospital Center Claudia Werner,
Slide 5: Clinical Rationale
Clinical Cli i lRRationale ti l Cervical Cancer Screening Current screening and triage methods cause •Delays in diagnosing significant disease •Excessive false positive rate Expensive billions of dollars of unnecessary cost LuViva Advanced Cervical Scan
Slide 6: LightTouch Technology Advancement
LightTouch ‐Technology Technology Advancement • Advances in the electro-optics, illumination sources and sensors •Efficiencies in performance and cost of multimodal hyperspectroscopy (MHS) Development of clinically relevant and convenient devices for the detection of cervical neoplasia LuViva Advanc
Slide 7: Potential Solution: Better Technology
Potential Solution: Better Technology Light In – Multiple wavelengths used Spectrometer to penetrate different tissue depths Results 1. Fluorescence Spectra - Reveal metabolic changes associated with neoplasia 2. Reflectance Spectra – Reveal morphological changes associated with neoplasia LuViva Adv
Slide 8: LightTouch Cervical Spectroscopy
LightTouch Cervical Spectroscopy Cervical Neoplasia Detection System • Measures fluorescence and reflectance spectra at multiple points on the cervix in one minute • Immediate, objective result • Low cost device and single patient use disposable • Built in video colposcope – permits visualization an
Slide 9: LightTouch Study Design
LightTouch Study Design • Each subject j served as own control • Referral Pap/HPV or other risk factor to qualify for study • On day of study, each subject had endocervical samples taken for Pap and HPV, followed by colposcopy and biopsy • Histology QA procedure used to reach diagnosis for each subj
Slide 10: Subject Accountability Tree
Subject Accountability Tree 2079 (Total number of subjects enrolled) – 70 withdrawn 2009 “Spectroscopic Evaluation of Cervical Neoplasia” 2004 - 2008 418 enrolled – 16 withdrawn 1661 enrolled – 54 withdrawn 402 1607 Beta Interim and Threshold (BIT) arm Primary Efficacy and Performance (PEP) arm Alph
Slide 11: Pivotal Trial Study Accrual Targets
Pivotal Trial Study y Accrual Targets g Estimated Number of Number of Total Prevalence of CIN2+ Cases Benign Cases Cases CIN 2+ (%) Required Required 20.0 165 - 213 414 - 1031 1600-1650 • Enrollment from June 2004 to September 2008 at seven diverse clinical sites • Follow upp data integration g star
Slide 12: LightTouch Condensed Procedure
LightTouch Condensed Procedure • Prep subject per gynecological exam; remove any excessive blood or mucus • Calibrate LightTouch (20 seconds) • Using live video feed, insert hollow sight tube through speculum into vaginal canal until tube makes contact with cervix, cervix is in focus and d cervical
Slide 13: Definitions
Definitions e to s • Final histology – Gold Standard – Pathology QA review involved blinded review by two independent expert pathologists – Up to two year histopathology follow-up after LightTouch study • Standard of Care – Includes Pap cytology, HPV testing and colposcopic impression LuViva Advance
Slide 14: Study Group
Study Group G oup • 1607 total • 1407 analyzed • Excluded women with discordant or insufficient hi t histopathology, th l ttraining i i cases (200) • 801 with two year follow up LuViva Advanced Cervical Scan
Slide 15: Up to Two Year Follow Up Results
Up p to Two Year Follow Up p Results Clinical Site Enrolled Follow up Data Not Lost to Follow Follow up Data Yet Made Available Up University of Texas Southwest 234 64 125 45 Emory University/Grady Hospital 348 48 81 219 University of Miami 313 0 116 197 University of Connecticut 394 0 164 230 Saint
Slide 16: LightTouch vs. Standard of Care
LightTouch vs. Standard of Care Detection of CIN2+ CIN2 Using Gold Standard QA Histopathology, follow-up • Standard St d d off care • LightTouch – Includes Pap cytology, HPV and – Multimodal spectroscopy colposcopy impression • CIN2+ • CIN2+ -Identified 242 - Identified 202 • 91% (242/266) • 76% (20
Slide 17: LightTouch vs. Standard of Care: 20% Increase in Identification of CIN2+
LightTouch vs. Standard of Care Detection of CIN2+ Using Gold Standard QA Histopathology, follow-up 20% Increase in identification of CIN2+ LuViva Advanced Cervical Scan
Slide 18: LightTouch Triage Tool
LightTouch Triage Tool Using the result of LightTouch 217/556 (39%) would not need •Normals‐217/556 •Normals further evaluation •CIN1‐ 176/585 / (30%) ( ) would not need further evaluation Significant cost savings LuViva Advanced Cervical Scan
Slide 19: Study Conclusions
Study Conclusions • Abnormal cytology had little value as a triage tool unless it was HSIL (high grade) • LightTouch detected 91% % off CIN2+ C compared with 76%% sensitivity ffor the current standard of care consisting of Pap, HPV and colposcopically directed biopsy • LightTouch would have reduced
Slide 20: Thank You
Thank You LuViva Advanced Cervical Scan
Slide 21: Study Results
Study Results Modality % Sensitivity % Specificity % Specificity CIN2+ (n = 266) CIN1 (n = 585) Normal (556) Standard of N/A N/A Care for 76** 76 (all referred to (all referred to referral* biopsy) biopsy) LightTouch 91 30 39 * Includes Pap cytology, HPV and colposcopy impression ** As determined by